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Fujifilm launches “FUJIFILM COVID-19 Ag Test”, a SARS-CoV-2 antigen rapid diagnostic test with a highly-sensitive detection technology based on silver halide amplification, in Europe

News Release

March 30, 2021

This news release is issued by FUJIFILM Corporation in Japan.
Fujifilm makes no representation that products on this news release are commercially available in all countries and regions(including US and EU). Approved uses of healthcare products vary by country and region.
Specifications and appearance of products are subject to change without notice.

TOKYO, Mar. 30, 2021 ― FUJIFILM Corporation (President: Kenji Sukeno) is pleased to announce that the “FUJIFILM COVID-19 Ag Test” (COVID-19 Ag Test), an antigen test kit for detecting SARS-CoV-2, will be released in Europe early April of 2021. The kit, to be sold as in-vitro diagnostic medical device, was developed with the use of highly-sensitive detection technology based on silver halide amplification used in the photo-developing process.

Amidst the global COVID-19 pandemic, rapid antigen test kits can be used not only for diagnostic purposes at medical institutions but also in periodic testing on workers at medical and aged-care facilities as well as for surveillance purposes at testing labs set up at airports and various event venues. Antigen testing is a quick and easy test method that is expected to be used in an even greater variety of situations. However, its sensitivity is lower than that of PCR testing, generating calls for sensitivity improvement.

The COVID-19 Ag Test was developed with antibodies supplied by Public University Corporation Yokohama City University (Kanagawa, Japan, Yokohama City University), which are capable of detecting SARS-CoV-2 antigens. Using cultured viruses and clinical specimens, Fujifilm and Yokohama City University jointly evaluated the detection capability of the antibodies in combination with Fujifilm’s proprietary silver amplification immunochromatography method*1. It has been subsequently confirmed that this method has higher virus-detecting capability compared to regular immunochromatography without silver amplification*2.

There have been reports of SARS-CoV-2 variants emerging around the world. The test kit has been confirmed to detect both UK and Brazilian variants*3.

Also, the test kit does not require any equipment. The result can be checked visually on the spot after applying an extracted sample into a cartridge and performing quick button operations.

The product has completed compliance with the EU IVD Directive*4, clearing the way for market launch in Europe. It will be introduced gradually to other countries and regions, including Asia, Mexico, Russia and the Middle East*5

The Fujifilm Group will continue to supply a wide range of products and services that cater to the needs of medical frontline to contribute to the efficiency of testing and the quality of medical care.

[Image]“FUJIFILM COVID-19 Ag Test”
  • *1 Immunochromatography is a testing method in which a specimen (e.g. nasopharyngeal swab) is processed in a reagent. If the specimen contains a test substance (e.g. virus), it binds with a labeled antibody in the reagent to generate an immune complex. When the complex is captured by an antibody which is coated beforehand along a detection line, the line manifests color, indicating a positive result (containing antigens). The method produces results easily and rapidly, and is therefore used frequently for detecting infectious diseases that requires quick treatment.
  • *2 https://www.medrxiv.org/content/10.1101/2021.01.27.21250659v1
  • *3 Verified with the UK variant (501Y.V1) and the Brazilian variant (501Y.V3)
  • *4 European Union (EU) In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)
  • *5 Product not available in all countries. Not approved for sale in the USA.
[The Silver Amplification Technology Applied in this Rapid Antigen Test]
[image][The Silver Amplification Technology Applied in this Rapid Antigen Test]

1. Product name

SARS-CoV-2 rapid antigen test kit
(Brand name: FUJIFILM COVID-19 Ag Test)

2. Main features

(1) High sensitivity achieved with the use of highly-sensitive detection technology based on silver halide amplification
The technology for developing photographic films has been used to amplify the size of the label on the antigens by approximately 100 times compared to the label of assays without this technology. Their enhanced visibility improves the test kit’s sensitivity, making it possible to achieve detection even with low viral load.
(2) High accuracy of detecting SARS-CoV2 antigens by using antibodies developed by Yokohama City University
The test kit differentiates SARS-CoV-2 antigens from those of conventional coronaviruses or influenza viruses and detects with high accuracy. Since the antibodies target the part of viral antigen that is less affected by mutation, it can detect recently-identified variants. The test kit has been confirmed to detect both UK and the Brazil variants accurately.
(3) No equipment needed and test results are produced on the spot
The test kit can be used anywhere as it does not require any equipment for reaction or scanning. The result can be checked visually on the spot after applying an extracted sample into a cartridge and performing quick button operations.
(4) Rapid testing that takes only 10 - 13 minutes.
An extracted sample, collected with a sterile swab, is dispensed into the test kit, which produces results in 10 - 13 minutes.

3. Main specifications

Product name

SARS-CoV-2 rapid antigen testing kit
“FUJIFILM COVID-19 Ag Test”

Measurement item

SARS-CoV-2 antigens

Specimen

nasopharyngeal swab

Reaction time

10 - 13 minutes

Storage

At room temperature (1 - 30℃)

Sales unit

10 kits / box

Contents

Test cartridge ........................................................10 tests
Extraction Reagent Solution R1 ............................10x0.4 mL
Sterile swab ...........................................................10 pieces
Tube rack (for extraction reagent solution R1).......1 piece
Filter (for extraction reagent solution R1) ..............10 pieces

[Image]FUJIFILM COVID-19 Ag Test

Contact

Media Contact

FUJIFILM Holding Corporation
Corporate Communications Division
Public Relations Group

Customer Contact

FUJIFILM Corporation
Medical Systems Business Division